International Technical Data Monograph
V-PRO® maX
Low Temperature Sterilization System

Table of Contents
1. Introduction  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  3
2. Principle of Operation  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  4
3. Consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  6
4. Performance Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  7
5. Materials Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  17
6. Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  19
7. Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  19

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1Introduction

This Technical Data Monograph illustrates the principles of operation and demonstrates the safety and efficacy of the V-PRO maX
Low Temperature Sterilization System. The summary test data for microbicidal efficacy, material compatibility, and biocompatibility
testing performed on the V-PRO maX Sterilization System are included.
The V-PRO maX Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and dried metal and nonmetal medical
devices used in healthcare facilities. The V-PRO maX Low Temperature Sterilization System performs three pre-programmed sterilization cycles; the Non Lumen, Lumen and Flexible Cycles.
The Non Lumen Cycle can sterilize instruments/devices with the following features1:• Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible
endoscopes and non-lumened instruments with stainless steel or titanium diffusion-restricted areas such as the hinged portion offorceps or scissors.
The Lumen Cycle can sterilize instruments/devices with the following features2:• Lumened and non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
• Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations:◦◦ Single channeled devices with a stainless lumen that is ≥ 0.77mm internal diameter (ID) and ≤ 500mm in length◦◦ Dual channeled devices with stainless steel lumens that are ≥ 0.77mm ID and ≤ 527mm in length◦◦ Triple channeled devices with stainless steel lumens that are▪▪ ≥1.2 mm ID and ≤ 275 mm in length▪▪ ≥1.8 mm ID and ≤ 310 mm in length		or▪▪ ≥2.8 mm ID and ≤ 317 mm in length
The Flexible Cycle can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and SurgicalCare) or bronchoscopes in either of two load configurations:
1. Two flexible endoscopes with a light cord (if not integral to the endoscope) and mat with no additional load3. The flexible endoscopes may contain either:• A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length• Or two lumens with:◦◦ One lumen that is ≥ 1 mm ID and ≤ 990 mm in length◦◦ And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length
2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including
instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors4. The flexible endoscopes my containeither:• A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length• Or two lumens with:◦◦ One lumen that is ≥ 1 mm ID and ≤ 990 mm in length◦◦ And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in lengthSingle-use, medical grade polyethylene (PE) and Teflon® (polytetrafluoroethylene) tubing with internal diameter ≥ 1 mm andlength ≤ 4 meters may be sterilized in the Flexible Cycle. Up to 26 pieces of tubing with no additional load may be sterilized.*
The principle features of the V-PRO maX Low Temperature Sterilization Systems include:• Large, easy to use touch screen control panel that is used to initiate and monitor the validated sterilization cycles.
• Proprietary hydrogen peroxide based sterilant which is provided in a multi-cycle container.
• Process monitoring and cycle documentation.
• Automatic load aeration.
* Tubing claims have not been reviewed by the Food and Drug Administration.

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• System designed for ease of use and maintenance.
• Easy installation – no utilities other than electricity required; no special venting required.
• Specially designed conditioning phase that aids in removal of residual moisture. All loads should be thoroughly dried before packaging and placing into the sterilizer.

The V-PRO maX Low Temperature Sterilization System consists of several components. These components include:• The V-PRO maX Sterilizer• VAPROX® HC Sterilant• Self-Contained Biological Indicator• Biological Indicator Test Packs• Chemical Indicator Tape
• External Process Indicators and Chemical Indicator Strips• Record Cards and Record Keeping Systems• Sterilization Trays, Instrument Organizers, and Silicone Mats
• Tyvek®5 Packaging
The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 22.7 kg (50 lbs).
The validation studies for all channel/lumen configurations were conducted using a maximum of twenty (20) lumens per load. Hospital loads should not exceed
the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two
pouches for a total weight of 8.9 kg (19.65 lbs).
3. The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).
4. The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load
were an additional instrument tray and one pouch for a total load weight of 10.9 kg (24 lbs).
5. Tyvek® is a registered trademark of DuPont.
1.
2.

2

V-PRO maX Low Temperature Sterilization System:
Principle of Operation

The V-PRO maX Low Temperature Sterilization System uses vaporized hydrogen peroxide or VHP to sterilize medical instruments.
Prior to sterilization, cleaned and dried instruments are packaged in wrapped trays, rigid containers or Tyvek pouches that are specifically designed for use with the V-PRO maX Sterilizer. The packaged instruments are placed on the Sterilizer’s two shelves and thesterilizer door is shut. Non Lumen, Lumen or Flexible Cycle is selected to initiate the sterilization process.

Non Lumen Cycle
The approximately 28-minute Non Lumen Cycle is used to sterilize instruments without lumens (i.e. surface sterilization) such asdefibrillator paddles, cables, cords, non-lumened rigid endoscopes (telescopes), batteries and cameras. The Non Lumen Cycle canbe used to sterilize instruments with stainless steel or titanium mated surfaces such as the hinged portion of forceps or scissors. If theload contains a stainless steel lumened instrument, the Lumen Cycle6 must be selected. If the load contains a flexible endoscope withlumens the Flexible cycle7 must be selected. If the load contains a mated surface other than stainless steel or titanium, the Lumen
Cycle or Flexible cycle must be selected. The prepared and packaged load is processed through a short moisture check phase during
which the chamber pressure is reduced to 1 Torr (or 0.13 kPa) and the moisture content of the load is verified to be acceptable. If the
moisture content is not acceptable, a short conditioning phase is initiated during which the chamber is evacuated to less than 1 Torr
(0.13 kPa) to aid in removal of excess moisture. After the optional conditioning phase, the moisture content of the load is verified tobe acceptable. The pressure in the sterilizer chamber is then reduced to 1 Torr (0.13 kPa) in preparation for injection of the VHP. The
sterilizer automatically vaporizes the correct amount of liquid hydrogen peroxide from the multiple-cycle VAPROX HC Sterilant cup.
After a two-minute hold segment, filtered air enters the sterilization chamber, increasing the chamber pressure to 500 Torr (or 66.7
kPa). After an additional 1 minute hold segment, the chamber pressure is again reduced to 1 Torr (0.13 kPa) in preparation for the
next injection of VHP. VHP is injected four times during each sterilization cycle. Each injection is called a sterilization pulse. Aftercompletion of the last VHP injection hold segment, the load is automatically aerated in the sterilizer. The chamber VHP is exhausted
through a catalytic converter that decomposes the VHP to water and oxygen. No special venting is required for operation of V-PRO
maX Sterilizer. At completion of the sterilization cycle, the load is removed and can be immediately used or stored prior to use. The
cycle is presented graphically in Figure 1.

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Figure 1. Pressure Graph of the V-PRO maX Sterilizer's Non Lumen Cycle
Moisture
Check1000.0

Sterilize

AeratePressure (Torr)

100.0

10.0

1.0
Pulse 1

Pulse 2

Pulse 3

Pulse 40.1

Time (min)Lumen Cycle
The approximately 55-minute cycle is used to sterilize instruments with stainless steel lumens6 and mated surfaces. The prepared andpackaged load is processed through a short conditioning phase during which the chamber is evacuated to less than 1 Torr (or 0.13kPa). After the conditioning phase, the moisture content of the load is verified to be acceptable. The pressure in the sterilizer chamberis then reduced to 0.4 Torr (or 0.05 kPa) in preparation for injection of VHP. The sterilizer automatically vaporizes the correct amountof liquid hydrogen peroxide from the multiple-cycle VAPROX HC Sterilant cup. After a six-minute hold segment, filtered air enters
the sterilization chamber, increasing the chamber pressure to 500 Torr (or 66.7 kPa). After an additional 2-minute hold segment, thechamber pressure is again reduced to 0.4 Torr (or 0.05 kPa) in preparation for the next injection of VHP. VHP is injected four times
during each sterilization cycle. Each injection is called a sterilization pulse. After completion of the last VHP injection hold segment,
the load is automatically aerated in the sterilizer. The chamber VHP is exhausted through a catalytic converter that decomposes the
VHP to water and oxygen. No special venting is required for operation of the V-PRO maX Sterilizer. At completion of the sterilization
cycle, the load is removed and can be immediately used or stored prior to use. The cycle is presented graphically in Figure 2.
Figure 2. Pressure Graph of the V-PRO maX Sterilizer's Lumen Cycle
Sterilize

Condition

Aerate1000.0Pressure (Torr)

100.0

10.0

1.0

Pulse 1

Pulse 2

Pulse 3

Pulse 4

0.1

0

2

4

6

8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 54 56

Time (min)Only stainless steel lumen configurations identified on page 3 can be sterilized using the Lumen Cycle.
7. Only flexible surgical endoscopes or bronchoscopes with dimensions identified on page 3 can be sterilized using the Flexible Cycle.
6.

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Flexible Cycle
The approximately 35-minute Flexible Cycle is used to sterilize surgical flexible endoscopes (such as those used in ENT, Urology andSurgical Care) and bronchoscopes with lumens and other non-lumened devices (i.e. surface sterilization) such as defibrillator paddles,
cables, cords, non-lumened rigid endoscopes (telescopes), batteries and cameras. The Flexible Cycle can be used to sterilize either
two single or dual channel flexible endoscopes in a cycle or a single flexible endoscope and non-lumened devices, inlcuding matedsurfaces [up to a total of 10.9 kg (24 lbs) per cycle].7 Stainless steel lumened instruments6 cannot be processed in the Flexible Cycle.
The prepared and packaged load is processed through a short moisture check phase during which the chamber pressure is reduced to
0.4 Torr (or 0.05 kPa) and the moisture content of the load is verified to be acceptable. If the moisture content is not acceptable, a shortconditioning phase is initiated during which the chamber is evacuated to less than 0.4 Torr (or 0.05 kPa) to aid in removal of excess
moisture. After the optional conditioning phase, the moisture content of the load is verified to be acceptable. The pressure in the sterilizer chamber is then reduced to 0.4 Torr (or 0.05 kPa) in preparation for injection of the VHP. The sterilizer automatically vaporizes
the correct amount of liquid hydrogen peroxide from the multiple-cycle VAPROX HC Sterilant cup. After a two-minute hold segment,
filtered air enters the sterilization chamber, increasing the chamber pressure to 500 Torr (or 66.7 kPa). After an additional 1 minutehold segment, the chamber pressure is again reduced to 0.4 Torr (or 0.05 kPa) in preparation for the next injection of VHP. VHP is
injected four times during each sterilization cycle. Each injection is called a sterilization pulse. After completion of the last VHP
injection hold segment, the load is automatically aerated in the sterilizer. The chamber VHP is exhausted through a catalytic converter
that decomposes the VHP to water and oxygen. No special venting is required for operation of V-PRO maX Sterilizer. At completionof the sterilization cycle, the load is removed and can be immediately used or stored prior to use. The cycle is presented graphically in
Figure 3.
Figure 3. Pressure Graph of V-PRO maX Sterilizer's Flexible Cycle
Sterilize

Condition

Aerate1000.0Pressure (Torr)

100.0

10.0

1.0

Pulse 1

Pulse 2

Pulse 3

Pulse 4

0.1

0

3

2

4

6

8

10

12

14

16

18

20

22

24

26

28

30

32

34

Time (min)Consumables

Sterilant
VAPROX HC Sterilant is a proprietary, 59% liquid hydrogen peroxide sterilant that is contained in a multi-cycle cup. The sealed cup
is placed into the sterilizer’s cup interface and the door is closed. The sterilizer confirms that the sterilant cup is within its expiration
date prior to automatically opening the sterilant cup. The sterilant cup has been engineered for safe and easy handling.

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Sterility Assurance and Sterile Packaging
The VERIFY™ biological and chemical indicator products and Tyvek Packaging have been designed and validated for use with the
V-PRO maX Low Temperature Sterilizer. Each product is designed to meet applicable International Standards. Only use products thathave been validated for the V-PRO maX Low Temperature Sterilization System. Failure to do so may result in a non-sterile device orineffective monitoring of the load.

Equipment Control
Equipment Control Products monitor the critical performance characteristics of the sterilization process. As part of any Sterility
Assurance Program, these products confirm that the equipment used is functioning correctly. Biological indicators, such as the
VERIFY™ V24I Self-Contained Biological Indicator, offer a fast means of weekly or daily microbial monitoring while test packs suchas the VERIFY™ V24I Challenge Pack provide assurance following installation, relocation or major repair.

Load Control
The V-PRO maX Low Temperature Sterilization System provides cycle printouts for verification of critical performance parameters. A
place is provided for the cycle reviewer’s initials or signature. Biological indicators such as the VERIFY V24I Self Contained Biological Indicator may also be used to monitor and release loads.

Pack Control
Chemical Indicator strips such as the VERIFY HPI Vaporized VH2O2 Process Indicator confirm that sterilant is able to penetrate
the packs to be sterilized. Each indicator provides the last check prior to use of the device. The indicator strips are designed to fit insterilization pouches or trays.

Process Control and Record Keeping
A variety of external process indicators, record cards, record envelopes and logs are available for use with the V-PRO maX Low Temperature Sterilization System. These items are used to prevent the mix up of sterilized items by labeling the packs prior to processing
and to ensure complete documentation of sterilization processes.

4

Performance Evaluation

Microbicidal Efficacy Testing
STERIS Corporation conducted tests to validate the microbicidal efficacy of the three cycles of the V-PRO maX Low Temperature
Sterilization System. Testing has been completed in the USA, France, Germany and Spain. The V-PRO maX Sterilizer is compliant to
ISO EN 14937 Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process. The following summarizes the test data demonstrating that these cycles
and VAPROX HC Sterilant are effective.

VHP Antimicrobial Efficacy
VHP has been used as a high level disinfectant and sterilant for over 20 years. VHP is known to be virucidal, bactericidal, fungicidal,
mycobactericidal, cysticidal and sporicidal. VHP has also been shown to safely reduce the risk of surface prion contamination. The
antimicrobial efficacy of VHP has been widely and independently published, with the following references given as examples:• Kahnert et al (2005). Decontamination with vaporized hydrogen peroxide is effective against Mycobacterium tuberculosis. Lettersin Applied Microbiology. 40: 448-52• Klapes and Vesley (1990). Vapor-phase hydrogen peroxide as a surface decontaminant and sterilant. Appl. Environ. Microbiol. 56:
503-506.
• Graham and Rickloff (1992). Development of VHP sterilization technology. J Healthc Mater Manage.10(8):54, 56-8.
• Gustin et al. (2002). The efficacy of vapour phase hydrogen peroxide against nematode infection. Contemporary Topics in Laboratory Animal Sciences. 41, 77-78.
• Heckert et al (1997). Efficacy of vaporized hydrogen peroxide against exotic animal viruses. Appl. Environ. Microbiol. 63: 39163918.

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• Hall et al (2007). Deactivation of the dimorphic fungi Histoplasma capsulatum, Blastomyces dermatitidis and Coccidioides im-

mitis using hydrogen peroxide vapor. Med Mycol. 46(2):189-91• Johnston et al (2005).Evaluation of hydrogen peroxide vapour as a method for the decontamination of surfaces contaminated with
Clostridium botulinum spores. J Microbiol Methods. 60(3): 403-11• Fichet et al (2004). Novel methods for disinfection of prion-contaminated medical devices. The Lancet 364: 521-526.
• Fichet et al (2007). Prion inactivation using a new gaseous hydrogen peroxide sterilisation process. J. Hosp. Infect. 67: 278-386.
• Kokubo et al (1998). Resistance of common environmental spores of the genus Bacillus to vapor hydrogen peroxide vapor. PDA
J. Pharm. Sci. Technol. 52: 228-231.
• McDonnell et al (2002). Vapor phase hydrogen peroxide decontamination of food contact surfaces. Dairy, Food Environ. Sanit.
22: 23-28.
• McDonnell et al (2001) Room Decontamination with Vapor Hydrogen Peroxide VHP for Environmental Control of Parvovirus.
Contemporary Topics in Laboratory Animal Sciences 40, 60-6.
• McDonnell (2007). In, Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance. ASM Press, Washington DC.
• Meszaros et al. (2005). Area Fumigation with Hydrogen Peroxide Vapor. Applied Biosafety, 10(2):91-100.
Testing with the V-PRO maX Sterilizer, using test conditions described in the EN antimicrobial test methods with modification for
testing a gas-based system, has confirmed this efficacy (based on EN14561, 2006). In this testing various microorganisms were inoculated onto either stainless steel coupons or glass slides in the presence of 10% serum to simulate ‘dirty’ conditions (unless otherwise
specified below). The inoculated coupons (≥106 cells or spores/coupon, unless otherwise stated below) were dried for ≥ 30 minutes(until visibly dry) and subjected to a half sterilization cycle in the Lumen Cycle. Coupons were then transferred into growth media andincubated under the appropriate environmental conditions for each test organism. A summary of the results are shown in Table 1.

Table 1. Microbicidal Efficacy of the Lumen Cycle
OrganismLog10 Reduction

Escherichia coli

Culture Conditions
Brain heart infusion, aerobic,
37°C
Trypticase soy, aerobic, 37°C
Reinforced clostridial
medium, anaerobic, 37°C
Trypticase soy, aerobic, 37°C

Enterococcus faecalis, vancomycin-resistant (VRE)

Trypticase soy, aerobic, 37°C

>6Enterococcus faecium, vancomycin-resistant (VRE)

Trypticase soy, aerobic, 37°C

>6

Klebsiella pneumoniae

Trypticase soy, aerobic, 37°C

>6

Pseudomonas aeruginosa

Trypticase soy, aerobic, 37°C

>6

Staphylococcus aureus, methicillin-resistant (MRSA)

Trypticase soy, aerobic, 37°C

>6Streptococcus pneumoniae

Trypticase soy, aerobic, 37°C
Grown by co-cell culture
with A. castellanii as asensitive culture method
Trophozoites or cysts, grownin cell culture
Inoculated directly
Encysted within
Acanthamoeba cysts>6Acinetobacter baumannii
Burkholderia cepacia
Clostridium difficile (spores)

L. pneumophila (9 isolates)
Acanthamoeba (2 strains)
Mycobacterium species (9 strains)
Mycobacterium species (6 strains)

>6
>6
>6
>6

>6
>5*
>6
No survivors*** 5 to 6 logs of amoebal cysts were deposited** Log reduction cannot be accurately calculated. It is not feasible to count the viable mycobacteria within untreated cysts, it is estimated that at least 1
mycobacteria was present for 10 cysts, resulting in > a 4 log reduction.

Complete reduction or a >6 log10 reduction of test organism was achieved for all of the tested organisms.
Conclusion
The V-PRO maX Sterilization System is effective against all test organisms, at half cycle and under soiled (‘dirty’) conditions.

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Sterility Assurance Level (SAL) Testing
The V-PRO maX Sterilizer is compliant to ISO EN 14937 Sterilization of health care products – General requirements for character-ization of a sterilizing agent and the development, validation and routine control of a sterilization process. As part of the demonstration of compliance, an SAL of 10-6 was established for the V-PRO maX Sterilization System by performing ½ cycle testing using
inoculated test articles to simulate medical instruments under worst case sterilization conditions.

Worst Case Test Conditions-Most Resistant Organism:
STERIS conducted vaporized hydrogen peroxide (VHP) resistance testing under greatly reduced exposure conditions with a variety oforganisms (Table 2) and bacterial endospores (Table 3) to identify the most resistant organism to VHP.

Table 2. Microbial Resistance to VHP*
Log of Recovered Population at Exposure Time (min)Test Organism

0

1

2

5

Geobacillus stearothermophilus spores, ATCC 7953

5.8

4.5

4.6

3.8

Mycobacterium terrae, ATCC 15755

5.9

5.2

4.2

†

Staphylococcus aureus, ATCC 6538

5.0

4.4

2.1

†

Pseudomonas aeruginosa, ATCC 15442

5.7

3.2

0.8

†

Salmonella choleraesuis, ATCC 10708

5.3

3.4

0.8

†

Aspergillus niger spores, ATCC 6275

5.1

2.6

†

†

Klebsiella pneumoniae, ATCC 4352

4.2

3.2

†

†

Trichophyton mentagrophytes spores, ATCC 18748

5.4

2.9

†

†

* Exposure to 1.8 g/min VHP in a 0.6m3 Isolator†† No organism recovered

Table 3. Bacterial Spore D-Values*
Test Organism

D-Value (seconds)

Geobacillus stearothermophilus spores, ATCC 7953

42.3

Bacillus subtilis spores, ATCC 19659

18.7

Clostridium sporogenes spores, ATCC 3584

15.6

Bacillus circulans spores, ATCC 4513

14.4

Bacillus cereus spores, ATCC 12826

9.9* Exposure to 1.8 g/min VHP in a 0.6m Isolator
3

Conclusion
Geobacillus stearothermophilus endospores are the most resistant organism and therefore were used to validate the SAL and microbicidal efficacy of the V-PRO maX Low Temperature Sterilization System.

Sterilizer Load
The SAL microbial tests were conducted in the presence of a validation load appropriate for the cycle. Additionally, in the Flexible
Cycle, single use PE and Teflon tubing were packaged in either double Tyvek pouches or double wrapped trays. Up to 26 pieces oftubing were processed at one time, with no additional load‡.

½ CycleFor the SAL studies, ½ cycle evaluation was conducted. The ½ cycle consisted of a moisture check/conditioning phase, 2 sterilization
pulses, and an aeration phase. This exposes the test articles to ½ the amount of vaporized hydrogen peroxide (2 sterilization pulses vs.
4 for a full cycle) for ½ of the total sterilant exposure time.

‡‡ Tubing claims have not been reviewed by the Food and Drug Administration.

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9Medical instrument material coupons (Table 4 and 8), mated configuration medical instrument coupons (Table 5), stainless steel lumens(Table 6), Teflon lumens (Table 7 and 8), or PE and Teflon tubing (Table 9) were challenged with 106 Geobacillus stearothermophilus
spores and dried. The test articles were placed within the validation load and exposed to a Lumen ½ Cycle, Non Lumen ½ Cycle or
Flexible ½ Cycle. After exposure, the test articles were cultured and the number sterile versus number tested determined. All of the
medical instrument materials, mated configuration materials, lumens and tubing were sterile after exposure to ½ Cycles of the V-PRO
maX Sterilizer. (Tables 4-8).
Due to the similarities between the Non Lumen and the Flexible Cycles, device materials evaluations conducted in the Non lumen Cycle
support the microbicidal efficacy of the Flexible Cycle.

Table 4. ½ Cycle Microbicidal Efficacy Evaluation – Medical Instrument Materials
Medical Instrument Material
Aluminum
Brass
DelrinEthyl vinyl acetate (EVA)
Glass
KratonNeoprene
Noryl (Polyphenylene Oxide)
Nylon
Polyether Ether Ketone (PEEK)Polymethyl methacrylate (PMMA)
Polycarbonate
Polyethylene
Polypropylene
Polystyrene
Polyvinyl chloride (PVC)
Polyurethane
Radel
Silicone
Stainless Steel
TeflonTitanium
Ultem (Polyetherimide)# Sterile/# Tested
Non Lumen Cycle*

Lumen Cycle

15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15

20/20
20/20
20/20
20/20
20/20
20/20
20/20
20/20
20/20
**
20/20
20/20
20/20
20/20
20/20
20/20
20/20
20/20
20/20
20/20
20/20
20/20
20/20

* Tests conducted in the Non Lumen Cycle qualify materials for sterilization in the Flexible Cycle.
** Tests conducted in the Non Lumen Cycle qualify materials for sterilization in the Lumen Cycle.

Table 5. ½ Cycle Microbicidal Efficacy Evaluation - Mated Instrument Materials
Material
Stainless Steel
Titanium
Delrin
Ultem
Radel
Noryl

Coupon Pairs Sterile/Pairs Tested
Non Lumen Cycle

Flexible Cycle**

6/6
6/6

***
***
6/6
6/6
6/6
6/6

N/A*

* N/A = Not Applicable. The Non Lumen Cycle is only intended to sterilize stainless steel or titanium mated surfaces.
** Tests conducted in the Flexible Cycle qualify materials for sterilization in the Lumen Cycle.
*** Tests conducted in the Non Lumen Cycle qualify materials for sterilization in the Flexible and Lumen Cycles.

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Table 6. ½ Cycle Microbicidal Efficacy Evaluation for theV-PRO maX Lumen Cycle
with Stainless Steel Lumens# Sterile/# Tested

Medical Instrument Material

Lumen Size
(ID** x Length mm)

Trial 1

Trial 2

Trial 3Single0.77 x 500

12/12

12/12

12/12

0.77 x 527

1/1

1/1

1/1

1.17 x 500

1/1

1/1

1/1

1.2 x 275

1/1

1/1

1/1

1.2 x 275

1/1

1/1

1/1

1.8 x 310

1/1

1/1

1/1

(2x1.5)* x 285

1/1

1/1

1/1

1.8 x 300

1/1

1/1

1/1

2.8 x 317

1/1

1/1

1/1

Dual

TripleTriple* Oval channel** Internal Diameter

Table 7. ½ Cycle Microbicidal Efficacy
Evaluation for the Flexible Cycle with Flexible
Endoscope Load

Table 8. ½ Cycle Microbicidal Efficacy
Evaluation for the Flexible Cycle with Mixed
Load

Lumen Size (ID x Length mm)# Lumens Sterile/# Tested

Test Article# Sterile/# Tested

1 x 1050

30/30

1 mm ID x 1050 mm
Length Lumens

15/15

Worst Case Material Coupons

9/9

Table 9. ½ Cycle Microbicidal Efficacy Evaluation for the Flexible
Cycle with Polyethylene and Teflon Tubing
Worst-case Test Article

No. of Test Articles Sterile/No. Tested

Double Pouched Teflon Tubing

3/3

Double Pouched Polyethylene Tubing

3/3

Double Wrapped Teflon Tubing

3/3

Double Wrapped Polyethylene Tubing

3/3

Conclusion
All of the device materials, mated device materials and lumens challenged with 106 Geobacillus stearothermophilus spores weresterile after exposure to a Lumen ½ Cycle, Non Lumen ½ Cycle, or Flexible ½ Cycle, as applicable, thereby establishing a SAL of 10-6
for the V-PRO maX Low Temperature Sterilization System.

Modified Total End Point Kill (VHP Dose Evaluation)
Using the inoculated steel lumen test articles described in Table 6 that had been placed within the validation load, various amountsof hydrogen peroxide were introduced into the chamber under Lumen ½ Cycle conditions. The number of sterile test articles versus
number tested was determined. All lumens were sterile at the normal sterilant concentration of 8.6 mg/L VHP as well as at the lower
concentration of 6.0 mg/L VHP (Table 10).

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Table 10. VHP Dose Evaluation of the V-PRO maX Sterilizer's
Lumen Cycle
VHP Concentration* (mg/L)# Sterile Lumens /# Tested

0.5

0/60

2.5

50/60

5.0

57/60

6.0

60/60

8.6

60/60

* Calculated Chamber Concentration

A similar experiment was conducted in the Non Lumen Cycle. Tests established the worst case challenge material to the Non Lumen
Cycle. The inoculated and dried worst case challenge material coupon test articles were placed within the validation load. Various
amounts of hydrogen peroxide were introduced into the chamber under Non Lumen ½ Cycle conditions. The number of sterile test
articles versus number tested was determined. All worst case material coupons were sterile at the normal sterilant concentration of 8.6
mg/L VHP as well as at the lower concentration of 6.0 mg/L VHP (Table 11).

Table 11. VHP Dose Evaluation of the V-PRO maX Sterilizer's Non Lumen Cycle
VHP Concentration* (mg/L)# Sterile Coupons /# Tested

2.5

9/18

5.0

16/18

6.0

18/18

8.6

18/18

* Calculated Chamber Concentration

The two load configurations for the Flexible Cycle, 2 flexible endoscopes and 1 flexible endoscope with non-lumened load (≥ 24.0
lbs, 10.9 kg), were exposed to varying concentrations of VHP and the number of sterile articles versus number tested was determined.
All lumens were sterile at the normal sterilant concentration of 8.6 mg/L VHP as well as at the lower concentration of 6.0 mg/L VHP(Tables 12 and 13).

Table 12. VHP Dose Evaluation of the V-PRO maX Sterilizer's Flexible
Cycle with Flexible Endoscope Load
VHP Concentration* (mg/L)# Sterile Lumens /# Tested

0.5

0/30

2.5

2/30

5.0

29/30

6.0

30/30

8.6

30/30

* Calculated Chamber Concentration

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Table 13. VHP Dose Evaluation of the V-PRO maX Sterilizer's Flexible Cycle with
Mixed Device Load
VHP Concentration* (mg/L)
0.5
2.5
5.0
6.0
8.6

# Sterile Lumens/ #Tested
0/15
0/15
10/15
15/15
15/15

# Sterile Coupons/ # Tested
0/9
7/9
9/9
9/9
9/9

* Calculated Chamber Concentration

Conclusion
The Non Lumen, Lumen and Flexible Cycles effectively kill 106 G. stearothermophilus spores, the most resistant organism, in a halfcycle evaluation at concentrations below the normal minimum injected concentration of 8.6 mg/L VHP.

AOAC Sporicidal Test Evaluation
The V-PRO maX sterilizer passes the current EN test methods for sporicidal activity, although these methods were modified to allow
for testing of a gas based sterilization process. Therefore, as an alternative test, the AOAC sporicidal carrier testing was performedin situ to demonstrate the sporicidal efficacy of the V-PRO maX Low Temperature Sterilization System. The AOAC sporicidal test
is considered one of the most challenging international tests for evaluating antimicrobial efficacy. The test uses two types of test
organisms (spores of Clostridium and Bacillus), in the presence of gross test soil (dirty conditions), on two different porous surface
carrier types (penicylinders and sutures).
Testing was performed as defined in the Official Methods of Analysis of the AOAC International Association of Official Analytical
Chemists, 17th Edition, 2000/2006, AOAC Official Method 966.04, “Sporicidal Activity of Disinfectants.” It is required that a
combination of at least 720 carriers are tested and all to demonstrate the absence of growth following exposure and incubation. All 720
carriers were confirmed to be sterile following exposure to the Non Lumen sterilization cycle using three separate lots of VAPROXHC Sterilant (Table 14). Sporicidal testing conducted in the Non Lumen Cycle verifies efficacy in the Flexible Cycle. The sameevaluation conducted in the Lumen Cycle yielded all sterile results.

Table 14. AOAC Sporicidal Carrier Evaluation in the Non Lumen Cycle*#Sterile/#Tested
21 Days

Carrier

24 Days (post heat-shock)

1° Tube2° Tube1° Tube2° TubeBacillus subtilis penicylinder

180/180

180/180

180/180

180/180

Bacillus subtilis suture loop

180/180

180/180

180/180

180/180

Clostridium sporogenes penicylinder

180/180

180/180

180/180

180/180

Clostridium sporogenes suture loop

180/180

180/180

180/180

180/180

Total

720/720720/720720/720720/720* Tests conducted in the Non Lumen Cycle also qualify the Flexible Cycle

Conclusion
The V-PRO maX Low Temperature Sterilization System effectively inactivates bacterial endospores when evaluated by the AOAC
carrier method. VAPROX HC Sterilant is sporicidal.

Medical Instrument Testing
STERIS Corporation conducted tests to validate the V-PRO maX Low Temperature Sterilization System’s ability to sterilize medical
instruments. Testing has been conducted under laboratory conditions in the USA, as well as in clinical testing in the USA, Germany
and Spain. Examples of these tests are given below. The following summarizes the test data demonstrating that the V-PRO maX
Sterilizer and VAPROX HC Sterilant are effective under simulated worst case use and clinical use conditions.

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Simulated Use Evaluation
Worst case medical instruments with regard to size and features that are challenging to sterilize, were inoculated with 106
G. stearothermophilus spores with 5% fetal bovine serum and 300 ppm AOAC hard water. The inoculated and dried medical instruments were processed through the Lumen, Non Lumen or Flexible Cycles. After exposure, the medical instrument sites were sampled
and evaluated for growth of the test organism. The number of sterile devices tested versus the number of devices tested was determined (Tables 15, 16, 17, and 18). All devices were sterile under worst case simulated use conditions.

Table 15. Non Lumen Cycle Simulated Use Evaluation
Medical Instrument

Inoculation Site

# Sterile / # Tested

Cavity Clip

Surface

3/3

Colorectal Intestinal Dilator

Surface

3/3

Slide for Cannula Tubing

Surface

3/3

Defibrillator

Spoon

3/3

High Frequency Cord

Surface

3/3Light Cable

Cable

3/3

Ocular Lens

Lens

3/3

Electrosurgical Forceps

Surface

3/3

Telescope

Ocular Surface

3/3

Surgical Scissors

Hinge (Mated Surface)

3/3

CameraLens

3/3

Battery

Housing

3/3

Non Lumened Flexible Endoscope

Insertion Tube

3/3

Table 16. Lumen Cycle Simulated Use Evaluation
Medical Instrument

Inoculation Site

# Sterile / # Tested

Surgical Scissors
Towel Forceps
Fixation Hooks/Retractor
Light Cable
CameraPacemaker Cables
Batteries

Hinge (Mated Surface)
Clamp
Tines
Cord
Lens
Lead Connector
Housing
Contact area with organizer
OcularHandleSpoons back
0.77 ID* x 527 mm length lumen
1.17 ID x 500 mm length lumens

3/3
3/3
3/3
3/3
3/3
3/3
3/3
3/3
3/3
3/3
3/3
3/3
3/3

1.2 ID x 275 mm length lumen

3/3

2.8 ID x 317 mm length lumen

3/3

Cystoscope
Defibrillator Paddles
Ureteroscope(dual channel)
Hysteroscope(triple channel)
Sheath (triple channel)* ID = Internal Diameter

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Table 17. Flexible Cycle Simulated Use Evaluation with Flexible Endoscope Load
Medical Instrument

Inoculation Site

# Sterile / # Tested

Flexible Epiduroscope

1 mm ID* x 1075 mm length lumen
1.5 mm ID x 700 mm length lumen
2 mm ID x 730 mm length lumens

3/3
3/3
3/3

Flexible Dual Channel
Bronchoscope* ID = Internal Diameter

Table 18. Flexible Cycle Simulated Use Evaluation with Mixed Device Load
Medical Instrument

Inoculation Site

# Sterile / # Tested

Flexible Epiduroscope

1 mm ID* x 1075 mm length lumen

3/3

Flexible Dual Channel
Ureterorenoscope

1 mm ID x 990 mm length and
1 mm ID x 850 mm length lumens

3/3

Cavity Clip

Surface

3/3

Colorectal Intestinal Dilator

Surface3/3

Flexible Nasopharyngoscope

Surface

3/3

Scissors

Hinge (Mated Surface)

3/3* ID = Internal Diameter

Conclusion
The V-PRO maX Low Temperature Sterilization Systems utilizing VAPROX HC Sterilant reproducibly sterilizes challenging medical
instruments inoculated with high levels of the most resistant organism, G. stearothermophilus spores.

Clinical Use Evaluation
The cycles of the V-PRO maX Low Temperature Sterilization System were evaluated in a clinical setting with medical instrumentsthat had been used in clinical procedures. The instruments were cleaned, dried, packaged and exposed to either the Non Lumen,
Lumen or Flexible Cycles. After exposure, selected medical instrument sites were sampled and evaluated for growth of organisms.
The number of sterile instrument sites versus the number of instrument sites tested was determined. All instruments were sterile underclinical use conditions (Tables 19, 20, 21, and 22).

Table 19. Non Lumen Cycle Clinical Use Evaluation
Medical Instrument

Selected Site

# Sterile / # Tested

Surgical Scissors

Hinge

3/3

Colorectal Intestinal Dilators

Surface

3/3Syringe Plunger

Tip

3/3

Defibrillator Paddle

Spoon

3/3

Light Cord

Cord

3/3

Bipolar Cable

Cable

3/3

Electrosurgical Forceps

Surface

3/3

CameraLens

3/3

Batteries

Housing

3/3

Telescope

Ocular Surface

3/3

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Table 20. Lumen Cycle Clinical Use Evaluation
Medical Instrument

Selected Site

# Sterile / # Tested

Surgical Scissors

Hinge

3/3

Towel Forceps

Clamp

3/3

Skin/Fixation Hooks/Retractor

Tines

3/3

Handle3/3

Spoon back

3/3

Light Cable

Cord

3/3

CameraLens

3/3

Pacemaker Cables

Lead Connector

3/3

Batteries

Housing

3/3

Contact area with organizer

3/3

Ocular

3/3

Defibrillator Paddles

Telescope

Ureteroscope (dual channel)

Hysteroscope (triple channel)orSheath (triple channel)

0.77 ID** x 510 mm length lumen,
1.17 ID x 500 mm length lumens
or0.85 ID x 520 mm length lumen,
1.4 ID x 520 mm length lumens
1.2 ID x 275 mm length lumen,
1.2 ID x 275 mm length lumen,
1.8 ID x 310 mm length lumens
or
2.8 ID x 317 mm length lumen
1.8 ID x 300 mm length lumen(2 x1.5)* ID x 285 mm length lumens

6/6

9/9

* crescent shaped lumen** ID = Internal Diameter

Table 21. Flexible Cycle Clinical Use Evaluation with Flexible Endoscope Load
Medical Instrument

Selected Site

# Sterile / # Tested

Flexible Laryngoscope

1.5 mm ID* x 768 mm length lumen

3/3

Flexible Dual Channel
Bronchoscope

1.5 mm ID x 700 mm length and
2.0 mm ID x 730 mm length lumen

3/3
3/3

* ID = Internal Diameter

Table 22. Flexible Cycle Clinical Use Evaluation with Mixed Device Load
Medical Instrument

Selected Site

# Sterile / # Tested
3/3

Flexible Endoscopes

1.5 mm ID* x 768 mm length or
1.0 mm ID x 825 mm length lumen
Insertion Tube Surface

3/3

Colorectal Intestinal Dilator

Surface

3/3

Surgical Scissors

Hinge

3/3

Syringe Plunger

Tip

3/3

Flexible Dual Channel
Ureterorenoscope

1 mm ID x 990 mm length and
1 mm ID x 850 mm length lumens

3/3* ID = Internal Diameter

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3/3

3/3

Conclusion
The Non Lumen, Lumen and Flexible Cycles utilizing VAPROX HC Sterilant reproducibly sterilize clinically used medical instruments.

Overall Conclusions of Microbicidal Efficacy Evaluations
STERIS Corporation has validated the microbicidal efficacy of the V-PRO maX Low Temperature Sterilization System:• VHP (vaporized hydrogen peroxide) or hydrogen peroxide gas is a well-recognized antimicrobial with efficacy shown against

viruses, bacteria, fungi (molds and yeasts), protozoa, prions, and bacterial spores. Bacterial spores, and in particular Geobacillus
stearothermophilus spores are known to be the most resistant organisms to VHP.
• An SAL of 10-6 has been established through ½ cycle testing and modified total end point kill analysis, in accordance to
ISO EN 14937.
• The System passed the AOAC Sporicidal Test, considered to be the most challenging sporicidal efficacy test internationally.
• Simulated and Clinical use testing has shown that instruments are sterile when processed in the V-PRO maX Low
Temperature Sterilizer utilizing VAPROX HC Sterilant.

5

Materials Compatibility

The sterilization process of the V-PRO maX Sterilizer is compatible with a wide range of medical instruments and materials.
STERIS Corporation performed medical instrument materials compatibility evaluations to ensure that the V-PRO maX Low
Temperature Sterilization System is safe for medical instruments. Representative medical instruments composed of a variety ofmaterials were subjected to 50 Lumen Cycles (worst case, longest sterilant exposure) with functional evaluations performed before
and after the tests. Table 23 lists the materials and type of instruments evaluated for material compatibility.

Table 23. Material Compatibility
Materials
Aluminum

Instrument Evaluated

Cosmetic Change

Telescope

None

Wide Field Vitrectomy Lens

Loss of black color

Functionality
Pass

Resectoscope Working Element
Brass

High Frequency Cord
Defibrillator

None

Pass

None

Pass

Slight yellowing

Pass

None

Pass

None

Pass

Bridge Adapter
DelrinEVA
GlassHigh Frequency Cord
Defibrillator
Slide for Cannula Tubing
Telescope
Wide Field Vitrectomy Lens
Cavity Clip

KratonPiston Syringe withThumb Control Ring
Non-vented Luer Dispenser Tip Cap
Pediatric Tuohy Borst Adapter

Neoprene

Neoprene Rubber Tubing

None

Pass

Noryl

STERIS V-PRO Sterilization Tray

None

Pass

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Table 23. Material Compatibility (continued)
Materials

Nylon

Instrument Evaluated

Cosmetic Change

Functionality

High Frequency Cord

Yes

Fail after 39th Cycle*

Resectoscope Sheath
Resectoscope Obturator

FadingPass

Pediatric Tuohy Borst Adapter

None

PEEK

Endoscope

None

Pass

PMMA

Contact

None

Pass

Polycarbonate

Reusable Nebulizer

None

Pass

Polyethylene

Piston Syringe with Thumb Control Ring

None

Pass

None

Pass

Defibrillator
Forceps
Polypropylene

Piston Syringe with Thumb Control Ring
Reusable Nebulizer
STERIS V-PRO Sterilization Tray

Polystyrene

Non-vented Luer Dispenser Tip Cap

None

Pass

Polyurethane

Flexible Endoscope

None

Pass

None

Pass

None

Pass

None

Pass

PTFE
PVC
Radel

Working Element
High Frequency Cord
Pediatric Tuohy Borst Adapter
Reusable Nebulizer
Adapter for STERIS SYSTEM 1
Resectoscope Working Element
High Frequency Cord

Silicone

Stainless Steel

Titanium
Ultem

Defibrillator

None
Pass

Forceps
Wide Field Vitrectomy Lens

Slight Discoloration

Reusable Nebulizer

None

Resectoscope Working Element
Microsurgical Scissors
Telescope
Resectoscope Sheath
Resectoscope Obturator
ForcepsBone Chisel
Bridge Adapter
Probe Tip
STERIS V-PRO Sterilization Tray
Bulldog Clamp
Instrument Tray

Slight discoloration

None

None
None

Pass

Pass
Pass

* See Operator Manual for specific information on compatible materials. Some grades of Nylon, Delrin, and Radel devices may have limited life after repeatedsterilization.

Conclusion
Exposure to numerous cycles in the V-PRO maX Sterilizer does not significantly affect the appearance or functionality of mostmedical instruments.

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6

SafetyThe toxicology of hydrogen peroxide (H2O2) is well understood in the scientific literature. A thorough risk assessment of hydrogen
peroxide was completed in 2003 by the European Union. The by-products from hydrogen peroxide sterilization, formed upon decomposition, are water (H2O) and oxygen gas (O2).
2 H2O22 H2O + O2

These by-products do not present toxicity concerns to the user. Safeguards are in place to protect against potential exposure tohydrogen peroxide.

Liquid Peroxide
Under normal conditions of use, the Sterilizer operator is not exposed to the contents of the VAPROX HC Sterilant cup (59%hydrogen peroxide). The sterilant cup is sealed, and the user cannot access the sterilant without physically damaging the cup. A SDS isprovided to advise the user on safe handling practices.

Hydrogen Peroxide Vapors
The user places a sealed, vented sterilant cup into the Sterilizer. The Sterilizer automatically dispenses and injects hydrogen peroxide
into the low pressure chamber. At the end of each sterilization pulse, hydrogen peroxide vapor is removed from the chamber througha cata-lytic converter which converts the hydrogen peroxide into water and oxygen. To confirm this, the environment around thesterilizer was monitored under simulated use conditions for acceptable VHP levels during typical sterilization cycle conditions. The
levels were >20 times lower than the OSHA hydrogen peroxide gas Time Weighted Average (TWA) limit of 1 ppm. Testing withmultiple V-PRO Sterilizers verified that the sterilizers' PEL was less than the 1 ppm TWA limit and, in a 15-minute evaluation of theuser’s breathing zone, there was no detectable hydrogen peroxide.

Hydrogen Peroxide on Medical Instruments or Packaging
Biocompatibility testing was conducted for commonly used medical device materials after sterilization in the V-PRO maX Sterilizer
to verify effective removal of residuals. As part of the testing, cytotoxicity screening evaluations were conducted. Cytotoxicity is anextremely sensitive methodology that can identify a material as causing a positive cytotoxic response even though that material has anestablished history of safe clinical use. Therefore, the results obtained after processing in the V-PRO maX Sterilizer were comparedto those obtained using a similar technology that has been in clinical use for over fifteen years. In addition to cytotoxicity evaluations,ocular irritation, acute systemic toxicology, intracutaneous irritation and blood compatibility evaluations were performed. The resultsfrom these tests demonstrate that items processed in the V-PRO maX Sterilization System do not have their innate biocompatible
characteristics altered or compromised.
In accordance with ISO EN 10993-17 Biological evaluation of medical devices- Part 17: Establishment of allowable limits forleachable substances, a risk analysis was conducted and safe levels of residual hydrogen peroxide were established. A risk assessment
completed by the European Commission (2003) was used as primary source document for this assessment. The V-PRO maX Sterilization System was shown to reduce the levels of residues on representative medical devices (12 medical devices including flexible
endoscopes, resectoscope and forceps) to well below the established residue limits (greater than 9 to 800 fold lower than the allowable
residue limit for internal tissue contact established in accordance with ISO 10993-17) proving that the V-PRO maX Sterilizer effectively eliminates toxic process residuals.

7

Conclusion

The V-PRO maX Low Temperature Sterilization System can be used to safely and effectively terminally sterilize properly prepared(cleaned, rinsed and dried) metal and nonmetal medical devices used in healthcare facilities.

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STERIS Corporation
5960 Heisley Road
Mentor, OH 44060-1834 • USA
440-354-2600 • 800-548-4873
www.steris.com

Document #10248284 Rev. B (M3665GB)©2017 STERIS Corporation
All Rights Reserved

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